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Mutual Quinine Approved For Malaria; Unapproved Versions Could Be Pulled

Executive Summary

FDA will hold an internal meeting in early September to discuss the fate of unapproved quinine products on the market following its first NDA approval for quinine sulfate to treat malaria

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Rx quinine sulfate for treating leg cramps requires NDA/ANDA approval, FDA informs 44 firms.

Rx QUININE SULFATE FOR LEG CRAMPS IS "NEW DRUG" REQUIRING APPROVAL of an NDA or ANDA to remain on the market, FDA said in a Jan. 23 warning letter sent to 44 companies. The agency action follows a Sept. 8 citizen petition from Public Citizen's Health Research Group requesting that FDA extend to prescription products its decision that OTC quinine products are not generally recognized as safe and effective for leg cramps ("The Pink Sheet" Sept. 12, 1994, T&G-4).

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